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NCT02870738 · ClinicalTrials.gov registry record · Phase 2
Bladder Directed vs. Pelvic Floor Therapy in IC/BPS
A Phase 2 study of Painful Bladder Syndrome and Cystitis, Interstitial, sponsored by Corewell Health East.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 128
- Enrollment target
- 1
- Study location
NCT02870738: Recruiting Phase 2 study of Painful Bladder Syndrome and Cystitis, Interstitial, sponsored by Corewell Health East.
NCT02870738 is a Phase 2 study of Painful Bladder Syndrome and Cystitis, Interstitial that is actively recruiting participants, run by Corewell Health East. The registered enrollment target is 128 participants, below the 164-participant average among 4 other Painful Bladder Syndrome trials with a reported enrollment target (22% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02870738, a Phase 2 study of Painful Bladder Syndrome and Cystitis, Interstitial, is actively recruiting participants, sponsored by Corewell Health East.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 128 participants
- Enrollment target
- 1
- Study location
Study Summary
Women with interstitial cystitis/bladder pain syndrome (IC/BPS) have debilitating urinary frequency and urgency, and chronic pelvic or bladder pain perceived to be related to the bladder. Although many clinicians think that IC/BPS symptoms result from a bladder problem, tight pelvic floor muscles can cause similar symptoms and might be responsible for ICBPS symptoms instead of the bladder. Inadequate assessment of the problem leads to delays in treatment and often years of suffering. This clinical trial will test a bladder directed therapy (bladder instillations) compared to a course of pelvic floor physical therapy (PFPT) to assess the role of the pelvic floor as a major contributor to pelvic pain and voiding dysfunction in adult women with non-ulcerative IC/BPS. Early assessment of the pelvic floor muscles in patients with IC/BPS symptoms may prevent common delays in proper diagnosis and allow for early, more effective treatment.
Primary Outcome
Proportion of patients in each treatment arm that report Marked or Moderate improvement in symptoms on Global Response Assessments at Week 9 (one week after last treatment)
Conditions Studied
Interventions
- PROCEDURE Pelvic Floor Physical Therapy
- DRUG Bladder Instillations
Study Locations (1)
Michigan
- Corewell Health William Beaumont University Hospital - Royal Oak
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2017-04-21 |
| Est. Completion | 2026-08 |
| Phase | Phase 2 |
What NCT02870738 shows while recruiting
NCT02870738 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 164-participant average among 4 other Painful Bladder Syndrome trials with a reported enrollment target (22% lower).
The record links to 2 conditions, with Painful Bladder Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Pelvic Floor Physical Therapy is the first listed.
NCT02870738 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT02870738 about?
NCT02870738 is a clinical study titled "Bladder Directed vs. Pelvic Floor Therapy in IC/BPS". Women with interstitial cystitis/bladder pain syndrome (IC/BPS) have debilitating urinary frequency and urgency, and chronic pelvic or bladder pain perceived to be related to the bladder. Although many clinicians think that IC/BPS symptoms result from a bladder problem, tight pelvic floor muscles ca...
What is the current status of trial NCT02870738?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2017-04-21. Estimated completion is 2026-08.
What conditions does trial NCT02870738 study?
This clinical trial studies the following conditions: Painful Bladder Syndrome, Cystitis, Interstitial.
What interventions are being tested in trial NCT02870738?
The interventions under investigation include: Pelvic Floor Physical Therapy (PROCEDURE), Bladder Instillations (DRUG).
Who is sponsoring clinical trial NCT02870738?
This trial is sponsored by Corewell Health East, which has 106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02870738 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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